Remediation Director
Location:
McPherson , Kansas
Posted:
December 13, 2017
Reference:
1050099

Role Summary: The Remediation Quality Director is focused on strengthening of site Quality systems through leading compliance remediation activities at the McPherson site pharmaceutical manufacturing facility per the defined Quality Improvement Plan. Activities may include oversight, assessments, review and approval of test plans, change requests, protocols and document revisions as required to meet regulatory and cGMP requirements across laboratory, quality assurance, quality culture, investigation, and training remediation focus areas. Examples: • Lead the development of detailed Quality System assessments and resulting remediation timelines • Develop industry leading approaches to Quality System enhancements • Provide oversight and guidance to team execution of the remediation strategy • Preview/provide feedback and technical/scientific support on project deliverables, i.e. remediation strategy, plan reports, etc. • Monitor and communicate progress to ensure commitment actions are completed according to the defined plan. Role Responsibilities: • Direct up to ten professionals in the execution of Quality remediation activities • Responsible for reporting progress on remediation activities to the Program Management Office for presentation to Regulatory Agencies and Pfizer senior management team. • Facilitates resolution and appropriate escalation of competing priorities and risks with stakeholders to ensure project success. • Engages, influences, and coordinates all functions needed to execute/implement projects. • Preview/provide feedback and technical/scientific support on any project deliverables, ie. remediation strategy, plan reports, resource needs, etc. • Recommends sustainability plan for post-remediation activities. Qualifications: • BS in Business, Engineering or Technical related field required • 10+ years' experience in pharmaceutical or similar regulated industry required with prior Quality leadership role; sterile injectable fill/finish Quality experience preferred • Experience authoring, review, etc. of procedures or training materials required • Experience interacting with world-wide regulatory agencies and developing response actions • Experience leading project teams or staff required Physical/Mental Requirements: -No unique physical requirements -Mental: -Remains organized &; positive in ambiguous and fast-paced, rapidly changing situations -Ability to analyze data from detailed schedule and risk management tools -Interface effectively with multiple stakeholder groups Non-Standard Work Schedule, Travel or Environment Requirements: Limited travel required. Non-standard work hour support of global conference calls, 24/7 manufacturing, etc. required when needed, though not typical of weekly requirements. EEO & Employment Eligibility Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer. Sun Shine Act Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative. Additional Offer Details: This job is Hospira Exempt US Grade: 21 Eligible for Relocation Package A career at Pfizer offers opportunity, ownership and impact. All over the world, Pfizer colleagues work together to positively impact health for everyone, everywhere. Our colleagues have the opportunity to grow and develop a career that offers both individual and company success; be part of an ownership culture that values diversity and where all colleagues are energized and engaged; and the ability to impact the health and lives of millions of people. Pfizer, a global leader in the bio-pharmaceutical industry, is continuously seeking top talent who are inspired by our purpose to innovate to bring therapies to patients that significantly improve their lives. Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.


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